Passive respiratory therapy device

ABSTRACT

A respiratory therapy device including a housing and an interrupter valve assembly. The housing is sized for handling by a patient and defines a patient breathing passage extending from a patient end and through which a patient inhales and exhales air. The interrupter valve assembly is carried by the housing and includes a control port, a valve body, and a drive mechanism. Expiratory airflow is released from the patient breathing passage through the control port. The valve body is sized to at least partially obstruct fluid flow through the control port. The drive mechanism moves the valve body relative to the control port in response to the expiratory airflow such that the valve body repeatedly transitions between a position of maximum obstruction and a position of minimum obstruction relative to the control port to create an oscillatory positive expiratory pressure effect.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.11/559,288, entitled “Respiratory Therapy Device and Method” filed onNov. 13, 2006; the teachings of which are incorporated herein byreference.

BACKGROUND OF THE INVENTION

The present disclosure relates to respiratory therapy devices andmethods for administering breathing-relating treatments (e.g.,oscillatory, continuous, etc.) to a patient. More particularly, itrelates to standalone respiratory therapy devices capable of creatingoscillatory positive expiratory pressure pulses. One or more additionaltherapies (e.g., continuous positive airway pressure, continuouspositive expiratory pressure, delivery of aerosolized medication, etc.)are optionally available in some embodiments.

A wide variety of respiratory therapy devices are currently availablefor assisting, treating, or improving a patient's respiratory health.For example, positive airway pressure (PAP) has long been recognized tobe an effective tool in promoting bronchial hygiene by facilitatingimproved oxygenation, increased lung volumes, and reduced venous returnin patients with congestive heart failure. More recently, positiveairway pressure has been recognized as useful in promoting mobilizationand clearance of secretions (e.g., mucous) from a patient's lungs. Inthis regard, expiratory positive airway pressure (EPAP) in the form ofhigh frequency oscillation (HFO) of the patient's air column is arecognized technique that facilitates secretion removal. In generalterms, HFO reduces the viscosity of sputum in vitro, which in turn has apositive effect on clearance induced by an in vitro simulated cough. Inthis regard, HFO can be delivered or created via a force applied to thepatient's chest wall (i.e., chest physical therapy (CPT), such as anelectrically driven pad that vibrates against the patient's chest), orby applying forces directly to the patient's airway (i.e., breathingtreatment, such as high frequency airway oscillation). Many patients andcaregivers prefer the breathing treatment approach as it is lessobtrusive and can more easily be administered. To this end, PAPbronchial hygiene techniques have emerged as an effective alternative toCPT for expanding the lungs and mobilizing secretions.

In the context of high frequency oscillatory breathing treatments,various devices are available. In general terms, respiratory therapydevices typically include one or more tubular bodies through which apatient breaths, with the tubular body or bodies creating or defining apatient breathing circuit. With this in mind, the oscillatory airfloweffect can be created by periodically generating a pressure or positiveairflow in the patient breathing circuit during one or both of aninspiratory phase or expiratory phase of the patient's breathing cycle.For example, a positive expiratory pressure (PEP) can work “against” thepatient's breath during the expiratory phase of breathing. The pressurecan be generated by creating a periodic (or in some instancescontinuous) resistance or restriction in the patient breathing circuitto expiratory airflow from the patient, or by introducing a forced fluidflow (from a positive pressure gas source) into the patient's breathingcircuit in a direction opposite of the patient's exhaled air. With theairflow resistance approach, a separate, positive pressure gas source isnot required. More particularly, many oscillatory positive expiratorypressure (“oscillatory PEP”) therapy devices utilize the patient'sbreath alone to drive an oscillatory fluid flow restriction, and thuscan be referred to as “passive” devices (in contrast to an “active”respiratory therapy device that relies on a separate source of positivepressure gas as described below). Passive oscillatory PEP devices areself-administering and portable.

The Flutter® mucus clearance device (available from Axcan ScandipharmInc., of Birmingham, Ala.), is one example of an available passive,oscillatory PEP therapy device. In general terms, the Flutter device ispipe-shaped, with a steel ball in a “bowl” portion of a housing that isloosely covered by a perforated cap. The ball is situated within anairway path defined by the device's housing; when the patient exhalesinto the housing, then, the ball temporarily obstructs airflow, thuscreating an expiratory positive airway pressure. The bowl within whichthe ball is located allows the ball to repeatedly move (e.g., rolland/or bounce) or flutter to create an oscillatory or vibrationalresistance to the exhaled airflow. While relatively inexpensive andviable, the Flutter device is fairly sensitive, requiring the patient tomaintain the device at a particular angle to achieve a consistent PEPeffect. Other passive oscillatory positive expiratory pressure devices,such as the Acapella® vibratory PEP therapy system (available fromSmiths Medical of London, England) and the Quake® secretion clearancetherapy device (available from Thayer Medical Corp., of Tucson, Ariz.)are known alternatives to the Flutter device, and purport to be lesssensitive to the position in which the patient holds the device duringuse. While these and other portable oscillatory PEP therapy devices areviable, opportunities for improvement remain, and patients continue todesire more uniform oscillatory PEP results.

As an alternative to the passive oscillatory PEP devices describedabove, continuous high frequency oscillatory (CHFO) treatment systemsare also available. In general terms, the CHFO system includes ahand-held device establishing a patient breathing circuit to which asource of positive pressure gas (e.g., air, oxygen, etc.), is fluidlyconnected. The pressure source and/or the device further includeappropriate mechanisms (e.g., control valves provided as part of adriver unit apart from the hand-held device) that effectuateintermittent flow of gas into the patient breathing circuit, and thuspercussive ventilation of the patient's lungs. With this approach, thepatient breathes through a mouthpiece that delivers high-flow,“mini-bursts” of gas. During these percussive bursts, a continuousairway pressure above ambient is maintained while the pulsatilepercussive airflow periodically increases airway pressure. Eachpercussive cycle can be programmed by the patient or caregiver withcertain systems, and can be used throughout both inspiratory andexpiratory phases of the breathing cycle.

Examples of CHFO devices include the IPV® ventilator device (fromPercussionAire Corp., of Sandpoint, Id.) and a PercussiveNeb™ system(from Vortran Medical Technology 1, Inc., of Sacramento, Calif.). Theseand other similar “active” systems are readily capable of providing notonly CHFO treatments, but also other positive airflow modes of operation(e.g., continuous positive airway pressure (CPAP)). However, a positivepressure source is required, such that available active respiratorytherapy systems are not readily portable, and are relatively expensive(especially as compared to the passive oscillatory PEP devices describedabove). Oftentimes, then, active respiratory treatment systems are onlyavailable at the caregiver's facility, and the patient is unable tocontinue the respiratory therapy at home. Instead, a separate device,such as a portable, passive oscillatory PEP device as described abovemust also be provided. Further, the hand-held portion of someconventional active respiratory therapy systems must be connected to anappropriate driver unit that in turn is programmed to effectuate thedesired fluid flow to the patient (e.g., CHFO, CPAP, etc.). That is tosay, the hand-held portion of some active systems is not self-operating,but instead relies on the driver unit for applications. Any efforts toaddress these and other limitations of available active respiratorytherapy devices would be well-received. This limitation represents asignificant drawback.

In light of the above, a need exists for improved passive oscillatoryPEP devices.

SUMMARY OF THE INVENTION

Some aspects in accordance with principles of the present disclosurerelate to an oscillating positive expiratory pressure therapy device foruse by a patient. The device includes a housing and an interrupter valveassembly. The housing is sized for handling by a patient and defines apatient breathing passage extending from a patient end and through whicha patient inhales and exhales air. The interrupter valve assembly iscarried by the housing and includes a control port, a valve body, and adrive mechanism. Expiratory airflow is released from the patientbreathing passage through the control port. The valve body is sized toat least partially obstruct fluid flow through the control port.Finally, the drive mechanism is provided to rotate the valve bodyrelative to the control port in response to the expiratory airflow. Withthis in mind, the interrupter valve assembly is configured such thatwith rotation, the valve body repeatedly transitions between a positionof maximum obstruction and a position of minimum obstruction relative tothe control port. With this transitioning, then, an oscillatory positiveexpiratory pressure effect is imparted upon the patient otherwisebreathing through the patient end.

Other aspects relate to an oscillating positive expiratory pressuretherapy device for use by a patient. The device includes a housing andan interrupter valve assembly. The housing is sized for handling by apatient and defines a patient breathing passage extending from a patientend and through which a patient to be treated inhales and exhales air.The interrupter valve assembly is carried by the housing and includes acontrol port, a valve body and a shaft. The control port is positionedsuch that expiratory airflow is released from the patient breathingpassage through the control port. The valve body is sized to at leastpartially obstruct fluid flow through the control port, with the shaftbeing assembled to control a position of the valve body relative to thecontrol port. In this regard, the shaft includes a first end attached tothe valve body and a second end opposite the first end. With this inmind, the interrupter valve assembly is configured to operate inresponse to expiratory airflow from the patient. More particularly, theinterrupter valve assembly selectively moves the valve body relative tothe control port to create an oscillatory positive expiratory pressureeffect, with a distance between the second end of the shaft and thecontrol port remaining fixed during operation of the interrupter valveassembly.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram illustrating a respiratory therapy device inaccordance with principles of the present disclosure;

FIG. 2 is an exploded, perspective view of a respiratory therapy devicein accordance with principles of the present disclosure;

FIG. 3A is a perspective view of a housing portion of the device of FIG.2;

FIG. 3B is a bottom view of the housing of FIG. 3A;

FIG. 4A is a longitudinal, cross-sectional view of the housing of FIG.3A taken along a patient supply inlet;

FIG. 4B is a rear, perspective view of a leading portion of the housingof FIG. 3A;

FIG. 4C is a longitudinal, cross-sectional view of the housing of FIG.3A taken along a drive supply inlet;

FIG. 5A is an exploded, perspective view of a drive mechanism portion ofthe device of FIG. 2;

FIG. 5B is a perspective view of the drive mechanism of FIG. 5A uponfinal assembly;

FIG. 6A is a perspective view illustrating partial assembly of thedevice of FIG. 2;

FIG. 6B is a longitudinal, cross-sectional view of the device of FIG. 2upon final assembly, taken along a patient supply inlet;

FIGS. 7A and 7B illustrate use of the device of FIG. 2 in a passivemode;

FIGS. 8A-8C illustrate use of the device of FIG. 2 in an active mode;

FIG. 9 is an exploded, perspective view of an alternative respiratorytherapy device in accordance with principles of the present invention;

FIG. 10 is a front, plan view of a trailing housing portion of thedevice of FIG. 9;

FIG. 11 is a perspective, cutaway view of a portion of the device ofFIG. 9 upon final assembly;

FIG. 12 is a exploded, perspective view illustrating assembly of thedevice of FIG. 9;

FIG. 13A is a perspective view of the device of FIG. 9;

FIG. 13B is a longitudinal, perspective view of the device of FIG. 9;

FIGS. 14A and 14B illustrate use of the device of FIG. 9 in whichairflow passes from a patient inlet to a chamber;

FIGS. 15A and 15B illustrate use of the device of FIG. 9 in whichairflow is obstructed from a patient inlet to a chamber;

FIG. 16 is a simplified, side sectional view of an alternativerespiratory therapy device in accordance with principles of the presentdisclosure;

FIG. 17 is an exploded, perspective view of another embodimentrespiratory therapy device in accordance with principles of the presentdisclosure;

FIG. 18A is a longitudinal, cross-sectional view of the device of FIG.17;

FIG. 18B is an enlarged view of a portion of FIG. 18A;

FIGS. 19A and 19B illustrate use of the device of FIG. 17;

FIG. 20 is a schematic illustration of an interrupter valve assemblyuseful with the device of FIG. 17;

FIGS. 21A and 21B are simplified, schematic illustrations of analternative interrupter valve assembly useful with the device of FIG.17;

FIG. 22 is a longitudinal, cross-sectional view of another embodimentrespiratory therapy device in accordance with principles of the presentdisclosure;

FIG. 23A is an exploded, perspective view of another embodimentrespiratory therapy device in accordance with principles of the presentdisclosure;

FIG. 23B is a perspective, cutaway view of the device of FIG. 23A uponfinal assembly;

FIG. 24 is an enlarged, perspective view of an orifice assembly portionof the device of FIG. 23A;

FIG. 25 is a schematic, electrical diagram of control circuitry usefulwith the device of FIG. 23A;

FIGS. 26A and 26B illustrate the device of FIG. 23A upon final assembly;

FIGS. 27A and 27B illustrate use of the device of FIG. 23A; and

FIG. 28 is a longitudinal, cross-sectional view of another embodimentrespiratory therapy device in accordance with principles of the presentdisclosure;

DETAILED DESCRIPTION OF THE INVENTION

In general terms, aspects of the present disclosure relate torespiratory therapy devices and related methods of use that are: 1)capable of operating in either of an active mode (e.g., CHFO) or apassive mode (e.g., oscillatory PEP); or 2) improved passive-onlyoscillatory PEP devices; or 3) improved active-only devices (CHFO and/orCPAP). As used throughout this specification, an “active” therapy deviceis in reference to a device that requires a separate source of positivepressure fluid to effectuate a designated respiratory therapy, whereas a“passive” therapy device is in reference to a device that delivers adesignated respiratory therapy in and of itself (i.e., a separate sourceof positive pressure fluid is not necessary). Thus, an “active-only”therapy device is one that must be connected to a separate source ofpositive pressure fluid. Conversely, a “passive-only” therapy device isone that is not configured to receive pressurized fluid from a separatesource. Given these definitions, several of the embodiments associatedwith this disclosure have base constructions appropriate forpassive-only, oscillatory PEP applications, as well as modified baseconstructions that promote use of the device as either an oscillatoryPEP therapy device or, when fluidly connected to a source of pressurizedfluid, as a CHFO therapy device. In yet other embodiments, the baseconstruction can be employed with an “active only” therapy device thatprovides CHFO therapy (and, in some embodiments, other respiratorytherapies such as CPAP) when connected to a source of positive pressurefluid. With any of these embodiments, optional features can be includedto facilitate delivery of aerosolized medication.

With the above understanding in mind, FIG. 1 is a block diagramillustrating features of a respiratory therapy device 30 in accordancewith some aspects of the present disclosure. In general terms, therespiratory therapy device 30 is adapted to operate in a passive mode(e.g., oscillatory PEP) and an active mode (e.g., CHFO and optionallyCPAP), and generally includes a housing 32 and an interrupter valveassembly 34. The housing 32 forms or maintains a patient inlet 36, atleast one chamber 38, an exhaust outlet 40, and at least one pressurizedfluid supply inlet 42. The interrupter valve assembly 34 includes atleast one control port 44 and a valve body 46. The control port(s) 44fluidly connects the patient inlet 36 and the chamber 38, whereas thevalve body 46 is adapted to selectively obstruct or interrupt fluid flowthrough the control port(s) 44. Details on the various components areprovided below. In general terms, however, by controlling or operatingthe valve body 46 to selectively obstruct (partially or completely) thecontrol port(s) 44, the interrupter valve assembly 34 altersairflow/pressure characteristics to and/or from the patient inlet 36.For example, where the supply inlet 42 is not connected to a separatesource of pressurized fluid 48, as a patient (not shown) exhales intothe patient inlet 36, the interrupter valve assembly 34 operates toperiodically at least partially close the control port(s) 44, therebyestablishing a resistance to airflow or back pressure in the patientinlet 36. This periodic back pressure, in turn, provides an oscillatoryPEP therapy. In addition, when the supply inlet 42 is fluidly connectedto the pressurized fluid source 48, the interrupter valve assembly 34operates to periodically at least partially interrupt fluid flow fromthe supply inlet 42 to the patient inlet 36. This interrupted supply ofpressure toward the patient serves as a CHFO therapy. As describedbelow, the device 30 can optionally include features that selectivelydisable all or a portion of the interrupter valve assembly 34 inconjunction with the supply of pressurized fluid to the supply inlet 42in providing a CPAP therapy (either along or simultaneous with CHFOtherapy).

In light of the above, the respiratory therapy device 30 provides bothactive and passive modes of operation, allowing the patient (not shown)to receive oscillatory PEP treatments with the device 30 at virtuallyany location, as well as CHFO treatments (and optionally other activetreatments such as CPAP) when the patient is at a location at which thepressurized fluid source 48 is available. The respiratory therapy device30 can further be configured to facilitate additional respiratorytherapy treatments, such as delivery of aerosolized medication (forexample via a nebulizer 50). The nebulizer 50 can be connected to a port(not shown) provided by the housing 32, or can include an appropriateconnection piece (e.g., T-connector or line) that is fluidly connectedto the housing 32 (e.g., to the patient inlet 36) when desired. Finally,while the pressurized fluid source 48 is shown apart from the housing32, in other embodiments, the pressurized fluid source 48 can beattached to, or carried by, the housing 32 (e.g., a pressurized canistermounted to the housing 32).

With the above in mind, the respiratory therapy device 30 can assume avariety of forms capable of operating in a passive mode (e.g.,oscillatory PEP therapy) and an active mode (e.g., CHFO therapy). Oneembodiment of a respiratory therapy device 60 providing these featuresis shown in FIG. 2. The therapy device 60 generally includes a housing62 (referenced generally) and an interrupter valve assembly 64(referenced generally). The housing 62 includes a leading section 66, atrailing section 68, and an end plate 69. The leading section 66 definesa patient inlet 70, whereas the trailing section 68 defines a firstchamber 72, a second chamber (hidden in the view of FIG. 2), an exhaustoutlet (hidden in FIG. 2), and one or more supply inlets 74. Theinterrupter valve assembly 64 includes a plate 76 forming one or morecontrol ports 78 (e.g., the control ports 78 a, 78 b), a valve body 80,and a drive mechanism 82. Details on the various components are providedbelow. In general terms, however, the drive mechanism 82 is retainedwithin the second chamber of the housing 62 and is assembled to thevalve body 80 for causing rotation thereof. The valve body 80, in turn,is located in close proximity to the control ports 78 such that rotationof the valve body 80 selectively opens and closes (e.g., partial orcomplete obstruction) the control ports 78 relative to the first chamber72 and the patient inlet 70. Finally, the supply inlet(s) 74 are fluidlyconnected to distribution points within the housing 62. During use, andin a passive mode of operation, the therapy device 60 generatesoscillatory PEP via operation of the drive mechanism 82 in response tothe patient's exhaled breath. In addition, the therapy device 60provides an active mode of operation in which the interrupter valveassembly 64 causes delivery of CHFO fluid flow to the patient inlet 70in acting upon positive fluid flow from the supply inlet(s) 74. In thisregard, a control means 84 (referenced generally) can be provided thatfacilitates operation of the therapy device 60 in a desired mode.

The housing 62 is shown in greater detail in FIGS. 3A and 3B upon finalassembly. The housing 62 is generally sized and shaped for convenienthandling by a patient, with the leading section 66 forming a mouthpiece86 sized for placement in the patient's mouth and through which thepatient's respiratory cycle interacts with the patient inlet 70. Themouthpiece 86 can be integrally formed with one or more othercomponent(s) of the housing 62, or can be separately formed andsubsequently assembled thereto.

The housing 62 can form or define fluid flow features in addition to thesupply inlets 74. For example, and as best shown in FIG. 3A, thetrailing section 68 forms a slot 90 as part of the control assembly 84(FIG. 2). As described below, the control assembly 84 can assume avariety of forms, but in some embodiments includes a body slidablydisposed with the slot 90. With alternative constructions, however, theslot 90 can be eliminated.

Relative to the top perspective view of FIG. 3A, the housing 62 canfurther form first and second relief port arrangements 92, 94. A thirdrelief port arrangement 96 can also be provided as shown in the bottomview of FIG. 3B. Finally, as best shown in FIG. 2, a fourth relief portarrangement 98 is provided within an interior of the housing 62.Operation of the therapy device 60 in connection with the relief portarrangements 92-98 is described in greater detail below. In generalterms, however, the relief port arrangements 92-98 each include one ormore apertures 99, and are adapted to maintain a valve structure (notshown), such as a one-way umbrella valve, that permits fluid flow intoor out of the aperture(s) 99 of the corresponding port arrangement 92-98in only a single direction. As such, the relief port arrangements 92-98can assume a variety of configurations differing from those illustrated.Similarly, additional relief port arrangements can be provided, and inother embodiments one or more of the relief port arrangements 92-98 canbe eliminated.

Returning to FIG. 2, the supply inlets 74, otherwise carried or formedby the housing 62, include, in some embodiments, first and secondpatient supply inlets 74 a, 74 b, as well as a drive supply inlet 74 c.The patient supply inlets 74 a, 74 b are fluidly connected to first andsecond nozzles 100 a, 100 b, respectively, each positioned to directfluid flow toward a corresponding one of the control ports 78 a, 78 b(otherwise formed by the plate 76). A relationship of the nozzles 100 a,100 b and the control ports 78 a, 78 b relative to the internal featuresof the housing 62 is provided below. It will be understood at theoutset, however, that while two of the control ports 78 a, 78 b areshown and described, in other embodiments, one or three (or more)control ports are also acceptable. Similarly, a nozzle/patient supplyinlet need not be provided for each of the control ports 78 a, 78 b(e.g., the patient supply inlet 74 b/nozzle 100 b can be eliminated), ortwo or more supply inlet/nozzles can be directed toward a single one ofthe control ports 78. Even further, two or more supply inlets 74 can befluidly associated with a single nozzle 100.

With the above in mind, FIG. 4A is a longitudinal cross-sectional viewof the housing 62 upon final assembly taken through the first patientsupply inlet 74 a. The leading portion 66, the trailing portion 68 andthe end plate 69 are generally assembled to one another as shown. As apoint of reference, the view of FIG. 4A further illustrates the controlmeans 84 in an open position relative to the housing 62, and reflectsthat the plate 76 can be an integral component of the housing 62.Regardless, the housing 62 is shown in FIG. 4A as defining the firstchamber 72, as well as a second chamber 101, and an exhaust chamber 102.The first chamber 72 is defined, in part, by the plate 76 and anintermediate wall 104, with the plate 76 fluidly separating the patientinlet 70 from the first chamber 72. In this regard, the patient inlet 70is fluidly connected to the first chamber 72 via the control ports 78(it being understood that only the first control port 78 a is visible inFIG. 4A). The first chamber 72 is separated from the second chamber 101by the intermediate wall 104, with fluid connection between the chambers72, 101 being provided by a passage 106. As described in greater detailbelow, the passage 106 can be fluidly closed via operation of thecontrol means 84. Regardless, the second chamber 101 is fluidlyconnected to the exhaust chamber 102 via an outlet opening 108. Thefirst chamber 72 is also fluidly connected to the exhaust chamber 102,via the fourth relief port arrangement 98. As a point of reference, FIG.4A reflects that a one-way valve structure 110 is associated with thefourth relief port 98 and is configured such that fluid flow can onlyoccur from the first chamber 72 to the exhaust chamber 102. Finally, theexhaust chamber 102 terminates at an exhaust outlet 112 that isotherwise open to ambient.

With the above conventions in mind, the first nozzle 100 a is positionedwithin the first chamber 72, and includes or defines an inlet end 114and an outlet end 116. The inlet end 114 is fluidly connected to thefirst patient supply inlet 74 a such that fluid flow through the firstpatient supply inlet 74 a is directed toward the outlet end 116. Theoutlet end 116, in turn, is aligned with the first control port 78 a soas to direct fluid flow from the first nozzle 100 a to the first controlport 78 a. In some embodiments, the first nozzle 100 a tapers indiameter from the inlet end 114 to the nozzle end 116, such that ajet-like fluid flow from the first patient supply inlet 74 a to thefirst control port 78 a is established. In this regard, ambient air canbe entrained into the fluid flow from the nozzle 100 a (as well as thenozzle 100 b) via the second relief port arrangement 94. A one-way valvestructure 118 is illustrated in FIG. 4A as applied to the relief portarrangement 94, and dictates that ambient air can only enter the firstchamber 72 (and thus the nozzle 100 fluid flow). Though not shown,operation of the valve structure 118 can be further controlled by acontrol mechanism that serves to selectively maintain the valvestructure 118 in a closed state (e.g., during a passive mode ofoperation as described below). In other embodiments, entrained ambientairflow within the first chamber 72 can be provided in a differentmanner (e.g., not including the relief port arrangement 94), or can beeliminated.

Regardless of whether ambient air is introduced into the first chamber72, a gap 120 (referenced generally) is established between the outletend 116 and the plate 76 (and thus the first control port 78 a). Asdescribed in greater detail below, the gap 120 is sized to facilitateassembly and movement of the valve body 80 (FIG. 2). Though not shown,the second patient supply inlet 74 b/second nozzle 100 b (FIG. 2) has asimilar construction and relationship relative to the plate 76/secondcontrol port 78 b. Thus, and as best shown in FIG. 4B, the first patientsupply inlet 74 a/nozzle 100 a directs positive pressure fluid from aseparate source toward the first control port 78 a, and the secondpatient supply inlet 74 b/nozzle 100 b directs positive pressure fluidtoward the second control port 78 b.

The drive supply inlet 74 c (FIG. 2) is similarly fluidly connected toan interior of the housing 62. In particular, the drive supply inlet 74c is fluidly connected to the second chamber 101 as shown in FIG. 4C. Asdescribed in greater detail below, a portion of the drive mechanism 82(FIG. 2) is retained within the second chamber 101, with fluid flow fromthe drive supply inlet 74 c serving to actuate or drive the drivemechanism 82 during an active mode of operation.

Returning to FIG. 2, the interrupter valve assembly 64 again includesthe valve body 80 that is driven by the drive mechanism 82. In someembodiments, the valve body 80 has a propeller-like construction, andincludes a base 130, a first valve plate segment 132, and a second valveplate segment 134. The base 130 is configured for assembly to acorresponding portion of the drive mechanism 82 as described below. Theplate segments 132, 134 extend in a radial fashion from the base 130,and each have a size and shape commensurate with a size and shape of acorresponding one the control ports 78 a, 78 b. For example, a sizeand/or shape of the valve plate segments 132, 134 can be identical,slightly smaller or slightly larger than a size and/or shape of thecontrol ports 78 a, 78 b. Further, in some embodiments, acircumferential position of the plate segments 132, 134 relative to thebase 130 corresponds with that of the control ports 78 a, 78 b such thatwhen the base 130 is centrally positioned between the control ports 132,134, the control port 78 a, 78 b can be simultaneously obstructed by theplate segments 132, 134. Thus, with the one embodiment of FIG. 2, thecontrol ports 78 a, 78 b are symmetrically opposed, and the valve platesegments 132, 134 are similarly oriented. Alternatively, a position ofthe valve plate segments 132, 134 can be spatially offset relative to aposition of the control ports 78 a, 78 b; with this alternativeconstruction, the control ports 78 a, 78 b are not simultaneouslyobstructed during movement of the valve body 80.

While the valve body 80 is shown as including two of the valve platesegments 132, 134, any other number, either greater or lesser is alsoacceptable, and the number of plate segment(s) 132, 134 provided neednot necessarily equal the number of control ports 78. In otherembodiments, for example, the valve body 80 is configured and positionedso as to fluidly interface with only one of the control ports 78 asdescribed below. Even further, the valve body 80 can have configurationsdiffering from the propeller-like construction shown. The valve body 80defines a contact face positioned to interact with the control port(s)78, the contact face, for example, may be flat. Regardless, the valvebody 80 is constructed such that all of the control port(s) 78 cansimultaneously be obstructed (e.g., completely blocked or less thancompletely blocked) by the valve body 80 in some embodiments.

The drive mechanism 82 is shown in greater detail in FIG. 5A. In someembodiments, the drive mechanism 82 is akin to a reverse roots blowerdevice and includes first and second lobe assemblies 140, 142, and firstand second gears 144, 146. The lobe assemblies 140, 142 can beidentical, with the first lobe assembly 140 including a lobe body 150and a shaft or member 152. The lobe body 150 includes three longitudinallobe projections 154, adjacent ones of which are separated by a valley156. Although three of the lobe projections 154/valleys 156 areillustrated in FIG. 5A, any other number is also acceptable; however,preferably at least two of the lobe projections 154/valleys 156 areprovided. Regardless, the shaft 152 is, in some embodiments, coaxiallymounted within the lobe body 150, extending from a first end 158 to asecond end 160. The first end 158 is sized for assembly to the valvebody base 130 (FIG. 2), whereas the second end 160 is sized for assemblyto the first gear 144. Other constructions are also contemplated such asintegrally molding or forming two or more of the lobe body 150, shaft154, and/or gear 140. The second lobe assembly 142 is similarlyconstructed, and generally includes a lobe body 162 coaxially maintainedby a shaft 164 that in turn is sized for assembly to and/or formed aspart of the second gear 146.

As shown in FIG. 5B, the lobe bodies 150, 162 are configured for meshedengagement (e.g., one of the lobe projections 154 of the second lobebody 162 nests within one of the valleys 156 of the first lobe body160), as are the first and second gears 144, 146 (it being understoodthat upon final assembly meshed engagement between the lobe bodies 150,162 and between the gears 144, 146 is simultaneously achieved). Withthis construction, then, the lobe assemblies 140, 142 rotate in tandem,but in opposite directions (e.g., relative to the orientation of FIG.5B, clockwise rotation of the first lobe body 150 translates intocounterclockwise rotation of the second lobe body 162). The shafts 152,164 are affixed to the corresponding lobe body 150, 162, respectively,such that rotation of the lobe bodies 150, 162 is translated directly tothe gears 144, 146, respectively, via the shafts 152, 164. Thus, thegears 144, 146 serve to maintain a desired intermeshing relationshipbetween the lobe bodies 150, 162. With the reverse roots blowerconfiguration of the drive mechanism 82, a relatively small force (e.g.,fluid flow) is required to initiate and maintain movement of the lobeassemblies 140, 142 at a desired rotational speed. In other embodiments,the number of lobe projections 154 can be increased so that the lobebodies 150, 162 effectively interface as gears such that the gears 144,146 can be eliminated. Regardless, upon final assembly, rotation of thefirst lobe assembly 140 translates into rotation of the valve body 80.

Assembly of the interrupter valve assembly 64 to the housing 62 ispartially shown in FIG. 6A. In particular, the valve body 80 ismaintained immediately adjacent the nozzles 100 a, 100 b via the shaft152 that otherwise extends into the first chamber 72. The shaft 164 ofthe second lobe assembly 142 (referenced generally in FIG. 6A, shown ingreater detail in FIG. 5A) also extends into, and is supported at, thefirst chamber 72 (it being understood that the opposite end of each ofthe shafts 152, 164 is also supported, for example at or by the endplate 69 (FIG. 2)). As shown in FIG. 6B, that otherwise is alongitudinal cross-sectional view taken through the first patient supplyinlet 74 a, the first lobe body 150 is maintained within the secondchamber 101, as is the second lobe body 162 (hidden in the view of FIG.6B). The shaft 152 maintains the valve body 80 such that the valve platesegments 132, 134 (it being understood that the second plate segment 134is hidden in the view of FIG. 6B) are located in the gap 120 between theoutlet end 116 of the first nozzle 100 a and the plate 76 (as well asbetween the second nozzle 10 b, that is otherwise hidden in the view ofFIG. 6B, and the plate 76). With rotation of the valve body 80 (via thedrive mechanism 82), the valve plate segments 132, 134 repeatedlyobstruct and “open” the control ports 78 relative to the first chamber72. In other words, the interrupter valve assembly 64 (referencedgenerally in FIG. 6B) operates to periodically stop or substantiallystop fluid flow between the patient inlet 68 and the first chamber 72 asdescribed below. While the valve body 80 has been described as beingassembled to the first shaft 152, in other embodiments, the second shaft164 rotates the valve body 80. In other embodiments, each of the shafts152, 164 can maintain a valve body.

With the above understanding in mind, forced movement of the drivemechanism 82 can occur in one of two manners that in turn are a functionof whether the device 60 is operating in a passive mode (e.g.,oscillatory PEP) or an active mode (e.g., CHFO). For example, in thepassive mode, the respiratory therapy device 60, and in particular thedrive mechanism 82, operates solely upon the patient's exhaled air orbreath. In this regard, and with reference to FIGS. 2 and 6B, in thepassive mode, the control means 84 is positioned such that the passage106 is open and fluidly connects the first and second chambers 72, 101.In some embodiments, the control means 84 includes a tab 166 slidablypositioned within the slot 90; in the “open” state of FIGS. 2 and 6B,the tab 166 is retracted from the slot 90. The control means 84 canassume a wide variety of other forms also capable of selectively openingor closing the passage 106. The supply inlets 74 a-74 c are fluidlyclosed or otherwise fluidly isolated from any external positive pressurefluid source (e.g., the pressurized fluid source 48 of FIG. 1 isdisconnected from the respiratory therapy device 60; fluid flow from thepressurized fluid source 48 is diverted from the supply inlets 74 a-74c; etc.). To this end, in some embodiments the supply inlets 74 a-74 ccan be exteriorly closed (for example, by a cap assembly (not shown)).

With the therapy device 60 configured as described above, the passivemode of operation can entail the mouthpiece 86 (or other patientinterface piece (not shown) otherwise attached to the mouthpiece 86) isinserted into the patient's mouth, and the patient being prompted tobreathe through the therapy device 60. During an inspiratory phase ofthe patient's breathing cycle, ambient air is readily drawn into thehousing 62 via the third relief port arrangement 96 (that otherwiseincludes a one-way valve structure 170 (FIG. 6B) controlling airflowtherethrough). Thus, the patient can easily and readily inhale air.

During the expiratory phase, exhaled airflow is directed from thepatient/mouthpiece 86, through the patient inlet 68, and toward theplate 76. The exhaled air can fluidly pass or flow from the patientinlet 68 to the first chamber 72 via the control ports 78 when thecontrol ports 78 are otherwise not completely obstructed by the valvebody 80 (and in particular the valve plate segments 132, 134). Anexample of this relationship is shown in FIG. 7A whereby the valve body80 has been rotated such that the plate segments 132, 134 are “away”from the control port 78 a (as well as the control port 78 b (hidden inthe view of FIG. 7A)). Thus, the exhaled air flows through the controlports 78 and into the first chamber 72 (represented by arrows in FIG.7A).

When the airflow into the first chamber 72 is at a pressure below theopening pressure of a valve structure 172 associated with the fourthrelief port arrangement 98, the apertures 99 of the relief portarrangement 98 remain fluidly closed, and all of the airflow through thefirst chamber 72 flows into the second chamber 101 via the passage 106(shown by arrows in FIG. 7A). Conversely, where the pressure within thefirst chamber 72 is above the bypass pressure associated with the valvestructure 172, the valve structure 172 “opens” to allow a portion of theairflow within the first chamber 72 to flow into the exhaust chamber102. In this manner, the pressure drop across the second chamber 101remains approximately equal with the opening pressure associated withthe valve structure 172. Alternatively, other valving and/or flowdimensions can also be employed

Airflow from the first chamber 72 into the second chamber 101 (via thepassage 106) serves to drive the drive mechanism 82. In particular,airflow within the second chamber 101 acts upon the lobe assemblies 140,142 (the lobe assembly 142 being hidden in FIG. 7A), causing operationthereof as a rotary positive blower. In general terms, and withadditional reference to FIG. 5B, airflow through the second chamber 101causes the lobe bodies 150, 162 to rotate, with airflow flowing throughor between the lobe bodies 150, 162, and then to the outlet opening 108.In this regard, the lobe assemblies 140, 142 operate as a roots blower,creating a pressure drop across the second chamber 101. As shown in FIG.7B, when the control ports 78 are periodically “covered” by the valveplate segments 132, 134, airflow through the control ports 78 isrestricted, creating a resistance to flow, or back pressure within thepatient inlet 68. This resistance to flow/back pressure occursperiodically (i.e., when the valve plate segments 132, 134 are rotatedaway from the control ports 78, back pressure within the patient inlet68 is released through the control ports 78). As a result, a desiredoscillatory PEP effect is created. Notably, the lobe assemblies 140, 142continue to rotate even as airflow through the passage 106 isperiodically interrupted due to inertia. Along these same lines, thelobe assemblies 140, 142 can be configured to act as a fly wheel,thereby reducing sensitivity to an opening time of the control ports 78.

In some embodiments, dimensional characteristics of the drive mechanism82 are correlated with the valve body 80 and the control port(s) 78 suchthat a flow rate of 10 lpm at 100 Pa, the valve body 80 generatesapproximately 15 pulses per second at the control ports 78, with thepressure pulses at approximately 3,000 Pa. At flow rates above 10 lpm,the valve structure 172 will open and may flutter to maintain inletpressure to the drive mechanism 82. The fourth relief port arrangement98 can be configured set to flow up to 20 lpm at 100 Pa (e.g., when thevalve structure 172 is “open”) so as to keep the back pressure and speedapproximately consistent from 10 lpm to 30 lpm. Alternatively, however,the therapy device 60 can be configured to exhibit other operationalcharacteristics.

With reference to FIGS. 2 and 8A, in the active mode of operation, thecontrol means 84 is operated to fluidly “close” the passage 106 (e.g.,the tab 166 is fully inserted into the slot 90). Further, the inlets 74a-74 c are fluidly connected to the pressurized fluid source 48 (FIG.1). For example, in some embodiments, a flow diverter assembly (notshown) can be employed to fluidly connect a single pressurized fluidsource (e.g., positive pressure gas such as air, oxygen, etc.) to eachof the supply inlets 74 a-74 c; alternatively, two or more fluid sourcescan be provided. Regardless, air, oxygen, or other gas is forced ordirected into the supply inlets 74 a-74 c. With specific reference toFIG. 8A, fluid flow into the first patient supply inlet 74 a isillustrated with an arrow A and is directed by the nozzle 100 a towardthe control port 78 a. Ambient air is entrained into the flow generatedby the nozzle 100 a via the second relief port arrangement 94 aspreviously described. In instances where the valve body 80, and inparticular the valve plate segments 132, 134, does not otherwiseobstruct the control port 78 a (relative to the nozzle 100 a), airflowcontinues through the control port 78 a and into the patient inlet 68.Though hidden in the view of FIG. 8A, a similar relationship isestablished between the second patient supply inlet 74 b/second nozzle100 b and the second control port 78 a.

Conversely, and as shown in FIG. 8B, when the control port 78 a and thecontrol port 78 b (hidden in FIG. 8B) are obstructed or “closed” via thevalve plate segments 132, 134, airflow from the nozzles 100 a, 100 b tothe patient inlet 68 is effectively stopped (it being understood that inthe view of FIG. 8B, only the first patient supply inlet 74 a/nozzle 100a, the first control port 78 a, and the first valve plate segment 132are visible). Once again, the drive mechanism 82 operates to continuallyrotate the valve body 80 relative to the control ports 78 a, 78 b, suchthat positive airflow from the supply inlets 74 to the patient inlet 68is “chopped” or oscillated so as to establish a CHFO treatment duringthe patient's breathing cycle (including at least the patient'sinspiratory phase).

To better ensure positive airflow toward the patient inlet 68 (and thusthe patient), the control means 84 closes the passage 106 such that allair within the first chamber 72 is forced through the control ports 78.In this regard, the drive mechanism 82, and in particular the lobeassemblies 140, 142, are acted upon and driven via fluid flow throughthe drive supply inlet 74 c as shown in FIG. 8C. In particular, forcedfluid flow from the pressurized fluid source 48 (FIG. 1) enters thesecond chamber 101 via the drive supply inlet 74 c and acts upon thelobe bodies 150, 162 as previously described. In other words, operationof the therapy device 60 in the active mode is independent of thepatient's breathing. Further, during the expiratory phase of thepatient's breathing cycle, pulsed gas flow from the nozzles 100 a, 100 bto the patient inlet 70 continues, creating an oscillatory PEP effect.As a point of reference, to minimize possible occurrences of stackedbreaths, exhaled air from the patient can be exhausted from the patientinlet 70 via the first relief port arrangement 92. For example, aone-way valve structure 174 can be assembled to the relief portarrangement 92, operating (in the active mode) to permit airflow throughthe relief port arrangement 92 to occur only outwardly from the patientinlet 70, thus freely permitting exhalation during periods when thecontrol ports 78 a, 78 b are blocked. An additional control mechanism(not shown) can further be provided that fluidly “closes” the reliefport arrangement 92/valve structure 174 when the device 60 operates inthe passive mode described above (i.e., all exhaled air from the patientpasses through the control ports 78 a, 78 b). Alternatively, the device60 can include other features (not shown) that facilitate exhausting ofexhaled air from the patient inlet 70, and/or the first relief portarrangement 92 can be eliminated. Along these same lines, in the activemode, the third relief port arrangement 96/valve structure 170 can bepermanently “closed” such that all inspiratory airflow is provided viathe control ports 78 a, 78 b.

While the device 60 has been described above as providing CHFO therapyvia essentially identical fluid flow from both of the patient inlets 74a, 74 b, in other embodiments, the device 60 can be configured toprovide a user with the ability to select or change the level of CHFO.For example, a mechanism (not shown) can be provided that causes fluidflow from one of the supply inlets 74 a or 74 b to not occur (where alower level of CHFO is desired) and continuously “blocks” thecorresponding control port 78 a or 78 b (e.g., the supply inlet 74 a or74 b can be fluidly uncoupled from the pressure source, and a closuremeans (not shown) actuated relative to the corresponding control port 78a or 78 b). Even further, the device 60 can be modified to incorporatethree of the supply inlets/nozzles 74/100 and three of the control ports78, with respective ones of the supply inlets/nozzles 74/100 beingselectively activated/deactivated and the corresponding control ports 78being selectively blocked so as to provide three levels of CHFO.Alternatively, the three supply inlets 74 can merge into a single nozzle100, again allowing a user to select a desired CHFO level by“activating” a desired number of the supply inlets 74.

In addition to the passive (e.g., oscillatory PEP) and active (e.g.,CHFO) modes described above, the therapy device 60 can further beconfigured to provide additional forms of respiratory therapy. Forexample, and returning to FIG. 1, the nebulizer 50 (FIG. 1) can befluidly connected to (and optionally disconnected from) the patientinlet 36 for providing aerosolized medication and other treatment to thepatient. With respect to the exemplary therapy device 60 of FIG. 2,then, the housing 62 can form or include an additional port (not shown)to which the nebulizer 50 is fluidly connected. In some embodiments, thenebulizer port is provided at or adjacent the mouthpiece 86 such thatnebulizer flow is directly to the patient and is not acted upon by theinterrupter valve assembly 64. Alternatively, the nebulizer port can beformed at the end plate 69, or at any other point along the housingbetween the end plate 69 and the mouthpiece 86. In other embodiments,one or more of the inlet ports 74 a-74 c can serve as a nebulizer port.In yet other embodiments, the nebulizer 50 can include a connectionpiece that is physically attached to the mouthpiece 86. Regardless,nebulized air can be provided during operation of the interrupter valveassembly 64 (in either passive or active modes). Alternatively, therespiratory therapy device 60 can be configured such that when in anebulizer mode of operation, the interrupter valve assembly 64 istemporarily “locked” such that the valve body 80 does not rotate and thevalve plate segments 132, 134 do not obstruct the control ports 78.

Alternatively or in addition, the therapy device 60 can be adapted toprovide CPAP therapy (with or without simultaneous aerosolized drugtreatment) when desired by fluidly connecting the pressurized fluidsource 48 (FIG. 1) to one or both of the patient supply inlets 74 a, 74b, while again “locking” the interrupter valve assembly 64. Inparticular, the interrupter valve assembly 64 is held in a lockedposition whereby the valve body 80 does not rotate, and the controlports 78 a, 78 b are not obstructed by the valve plate segments 132, 134such that positive airflow to the patient occurs continuously. Forexample, and with reference to FIGS. 5A and 8A, one or more mechanismscan be provided that, when actuated, decouple the first drive shaft 152from the first lobe body 150 (so that the drive shaft 152 does notrotate with rotation of the lobe body 150), and retains the valve body80 in the “open” position of FIG. 8A (e.g., magnet, body that capturesone or both of the valve plate segments 132, 134, etc.). Along thesesame lines, the device 60 can be modified to deliver a constant,baseline pressure CPAP therapy with or without simultaneous CHFOtreatment. For example, the interrupter valve assembly 64 can beconfigured such that the valve body 80 only affects fluid flow from thefirst supply inlet 74 a, whereas fluid flow from second supply inlet 74b is continuously supplied to the patient inlet 70. With this approach,the second supply inlet 74 b provides a specific, baseline pressure(e.g., 5 cm water) as CPAP therapy, whereas the interrupter valveassembly 64 acts upon fluid flow from the first supply inlet 74 a increating a CHFO effect as described above. In this regard, theinterrupter valve assembly 64 can be “locked” as described above duringperiods where CHFO therapy is not desired. In yet another, relatedembodiment, the device 60 can be configured to provide a varying,selectable level of CPAP. For example, a mechanism (not shown) can beincluded that partially restricts (on a continuous basis) the inlet end114 (FIG. 4A) and/or the exit end 116 (FIG. 4A) of the nozzle(s) 100, orthe corresponding supply inlet 74, a desired extent (thus dictating alevel of delivered CPAP). Alternatively, a controlled leak can beintroduced into the system (e.g., a relief port arrangement andcorresponding control valve that exhausts to ambient can be provided atone or both of the patient inlet 70 and/or the first chamber 72). Evenfurther, one or both of the patient inlets 74 can be selectively“activated” to provide CPAP therapy as described above (it beingunderstood that the level of CPAP will be greater where fluid flow isprovided through both of the patient inlets 74 as compared to just oneof the patient inlets 74).

In yet other embodiments, the device can be configured to optionallyprovide a continuous PEP therapy in the passive mode. In particular, theinterrupter valve assembly 64 is “locked” in an open state as previouslydescribed, and the supply inlets 74 are disconnected from thepressurized fluid source 48 (FIG. 1). As a result, the control ports 78serve as flow restrictors to exhaled air, thus creating or deliveringthe PEP effect.

Regardless of whether the additional modes of operation are provided,the therapy device 60 provides a marked advantage over previous designsby being operable in both the passive and active modes. For example, apatient can be given the therapy device 60 immediately followingsurgery, admission to the caregiver's facility (e.g., hospital), etc.,and instructed to use the therapy device 60 in the passive mode. Thisallows the patient to begin receiving oscillatory PEP therapy treatmentsimmediately. Subsequently, upon observation (x-rays, breath sounds,blood analysis, etc.) by the caregiver that a more aggressiveoscillatory therapy is required to aide with airway clearance and/orairway expansion, the therapy device 60 can then be connected to apressurized source (e.g., the pressurized fluid source 48 of FIG. 1) andswitched to the active mode. Following the active treatment, thetherapist can leave the therapy device 60 with a patient to allow thepatient to continue the passive therapy without the caregiver needing tobe present. In other words, the patient can continue to use the sametherapy device 60 at virtually any location away from the caregiver'sfacility.

Although the respiratory therapy device 60 has been described asproviding both passive and active modes of operation, in otherembodiments in accordance with the present disclosure, similarprinciples of operation can be employed in a passive-only or oscillatoryPEP device (that otherwise interacts with the patient's breathing). Forexample, an alternative embodiment respiratory therapy device 186 isshown in exploded form in FIG. 9. The therapy device 186 is similar inmany respects to the respiratory therapy device 60 (FIG. 2) previouslydescribed, and includes a housing 188 (referenced generally) and aninterrupter valve assembly 190. The housing 188 includes a leadingsection 192, an intermediate plate 194, a trailing section 196, and anend plate 198. The interrupter valve assembly 190 includes one or morecontrol ports 200 a, 200 b, a valve body 202, and a drive mechanism 204.As described in greater detail below, the drive mechanism 204 rotatesthe valve body 202 in response to exhaled airflow from the patient toperiodically obstruct or close the control ports 200 a, 200 b.

The leading section 192 of the housing 188 includes a tapered mouthpiece208, and forms or defines a patient inlet 210, whereas the trailingsection 196 forms a first chamber 212. The plate 194 separates thepatient inlet 210 and the first chamber 212, and forms the one or morecontrol ports 200 a, 200 b. As with previous embodiments, while two ofthe control ports 200 a, 200 b are shown, any other number, eitherlesser or greater, is also acceptable. Regardless, fluid flow betweenthe patient inlet 210 and the first chamber 212 is via the controlport(s) 200 a, 200 b.

The trailing section 196 further forms a second chamber 220 and, in someembodiments, an exhaust chamber (hidden in the view of FIG. 9). Thesecond chamber 220 is sized to receive a corresponding portion of thedrive mechanism 204 as described below, and is fluidly isolated from thefirst chamber 212 by an intermediate wall 222. In this regard, and asbest shown in FIG. 10, the intermediate wall 222 forms a passage 224through which fluid flow from the first chamber 212 (FIG. 9) to thesecond chamber 220 (referenced generally in FIG. 10) can occur. Inaddition, the intermediate wall 222 defines first and second holes 226a, 226 b sized to receive corresponding components of the drivemechanism 204 as described below. Finally, and returning to FIG. 9, theend plate 198 is adapted for assembly to the trailing section 196, andserves to close the second chamber 220. As shown, the end plate 198 canform grooves 228 sized to rotatably retain corresponding components ofthe drive mechanism 204 as described below.

The valve body 202 is similar to the valve body 80 (FIG. 2) previouslydescribed, and in some embodiments includes a base 230, a first valveplate segment 232, and a second valve plate segment 234. The valve platesegments 232, 234 are shaped and sized in accordance with the controlports 200 a, 200 b such that when aligned, the valve plate segments 232,234 can simultaneously obstruct or “block” the control ports 200 a, 200b. Regardless, the valve plate segments 232, 234 extend radially fromthe base 230 that is otherwise configured for affixment to acorresponding component of the drive mechanism 204.

The drive mechanism 204 is akin to a reverse roots blower assembly, andincludes first and second lobe assemblies 240, 242, and first and secondgears 244, 246. The lobe assemblies 240, 242 each include a lobe body250 a, 250 b coaxially mounted to, or integrally formed with, a shaft ormember 252 a, 252 b, respectively. The shafts 252 a, 252 b, in turn, areassembled to, or integrally formed with, a respective one of the gears244 or 246, with the valve body 202 being mounted to the shaft 252 a ofthe first lobe assembly 240. Upon final assembly, the lobe bodies 250 a,250 b interface with one another in a meshed fashion, as do the gears244, 246.

With initial reference to FIG. 11, assembly of the respiratory therapydevice 186 includes placement of the lobe bodies 250 a, 250 b/gears 244,246 within the second chamber 220 defined by the housing 188. As shown,the shafts 252 a, 252 b extend from the second chamber 220 and into thefirst chamber 212. The valve body 202 is assembled to the shaft 252 a ofthe first lobe assembly 240 (or the shaft 252 b of the second lobeassembly 242), and is thus located with the first chamber 212. Theintermediate wall 222 serves to fluidly isolate the first and secondchambers 212, 220, except at the passage 224.

The intermediate plate 194 and the leading section 192 are thenassembled to the trailing section 196 as shown in FIG. 12 (it beingunderstood that in some embodiments, the leading section 192 and theplate 194 can be integrally formed). In particular, upon assembly of theleading section 192/plate 194, the valve body 202 is associated with thecontrol port(s) 200 a, 200 b. For example, the valve body 202 ispositioned such that the valve plate segments 232, 234 selectively alignwith respective ones of the control ports 200 a, 200 b with rotation ofthe valve body 202. The valve body 202 defines a contact face, which canbe flat, for example, positioned to interact with the control port(s)200 a, 200 b. FIG. 13A illustrates the therapy device 186 upon finalassembly.

A relationship of the various components of the therapy device 186 arebest shown in the cross-sectional view of FIG. 13B. Once again, thepatient inlet 210 is fluidly connected to the first chamber 212 via thecontrol ports 200 a, 200 b (it being understood that only the firstcontrol port 200 a is visible in FIG. 13B). The valve body 202 ismaintained in the first chamber 212 such that the valve plate segments232, 234 (it being understood that only the first valve plate segment232 is seen in the view of FIG. 13B) are selectively aligned with thecontrol ports 200 a, 200 b so as to obstruct fluid flow between thepatient inlet 210 and the first chamber 212. The first chamber 212 isfluidly connected to the second chamber 220 via the passage 224. Thesecond chamber 220 maintains the lobe assemblies 240, 242 (it beingunderstood that only the first lobe assembly 240 is visible in the viewof FIG. 13B). Further, the second chamber 220 is fluidly connected to anexhaust chamber 254 via an outlet opening 256. The first chamber 212 isalso fluidly connected to the exhaust chamber 254 via a relief portarrangement 258 to which a valve assembly 260 (e.g., a one-way, umbrellavalve) is assembled. Finally, the exhaust chamber 254 is open to ambientat an exhaust outlet 262. As a point of reference, the exhaust chamber254 serves to minimize the opportunity for one or both of the outletopening 256 and/or the relief port arrangement 258 to inadvertently beobstructed during use. In other embodiments, however, the exhaustchamber 254 can be eliminated.

During use, operation of the interrupter valve assembly 190 includes thelobe assemblies 240, 242 rotating in response to airflow entering thesecond chamber 220 as described in greater detail below. Rotation of thefirst lobe assembly 240 causes the valve body 202 to similarly rotate,thus periodically moving the valve plate segments 232, 234 into and outof alignment with corresponding ones of the control ports 200 a, 200 b,creating an oscillatory PEP effect in the patient inlet 210 as thepatient exhales.

For example, with reference to FIGS. 14A and 14B, the mouthpiece 208 (orother component attached to the mouthpiece 208, such as a nebulizerconnector) is placed in the patient's mouth (not shown) and the patientperforms a breathing cycle through the patient inlet 210. During theinspiratory phase, ambient air readily enters the patient inlet 210 viaa relief port arrangement 266, the flow through which is controlled by aone-way valve structure 268 (such as an umbrella valve). During theexpiratory phase, exhaled air from the patient is directed through thepatient inlet 210 and toward the plate 194. With the valve body 202arrangement relative to the control ports 200 a, 200 b of FIGS. 14A and14B, the valve plate segments 232, 234 are not aligned with the controlports 200 a, 200 b such that the patient's exhaled air flows from thepatient inlet 210 through the control ports 200 a, 200 b, and into thefirst chamber 212. This flow pattern is represented by arrows in FIGS.14A and 14B. Airflow within the first chamber 212 flows through thepassage 224 and into the second chamber 220, and then interacts with thelobe assemblies 240, 242. In particular, airflow within the secondchamber 220 causes the lobe assemblies 240, 242 to rotate, with theairflow then exiting the second chamber 220 (at the outlet opening 256of FIG. 14A) to the exhaust chamber 254. Air within the exhaust chamber254 is then exhausted to the environment via the exhaust outlet 262.

As shown in FIGS. 14A and 14B, the valve structure 260 controls fluidflow through the relief port arrangement 258 between the first chamber212 and the exhaust chamber 254. In some embodiments, the valvestructure 260 is a one-way bypass valve having a predetermined openingor bypass pressure. With this in mind, so long as airflow within thefirst chamber 212 is below the opening pressure of the valve structure260, the valve structure 260 remains closed, such that all air flowsinto the second chamber 220 as described above. Where, however, pressurewithin the first chamber 212 is above the opening pressure of the valvestructure 260, the valve structure 260 will “open” and allow a portionof the air within the first chamber 212 to bypass the second chamber220/lobe assemblies 240, 242 and flow directly into the exhaust chamber254 via the relief port arrangement 258. In this manner, the pressuredrop across the second chamber 220 remains approximately equal to theopening pressure of the valve structure 260.

With rotation of the lobe assemblies 240, 242 in response to exhaled airentering the second chamber 220, the valve body 202 is caused to rotate.To account for instances in which the valve body 202 is initiallyaligned with control ports 200 a, 200 b (and thus may impede desiredairflow into the second chamber 200 sufficient to initiate rotation ofthe lobe assembles 240, 242), means (not shown) can be provided by whicha user can self-actuate movement of the valve body 282, a valved conduitcan be provided that directly fluidly connects the patient inlet 210with the second chamber 220, etc. Regardless, the valve plate segments232, 234 will periodically be aligned with a respective one of thecontrol ports 200 a, 200 b as shown, for example in FIGS. 15A and 15B.When so-aligned, exhaled air from the patient at the patient inlet 210is substantially prevented from passing through the control ports 200 a,200 b. As a result, a back pressure is generated within the patientinlet 210 that in turn is imparted upon the patient. This airflow isrepresented by arrows in FIGS. 15A and 15B. Because the valve body 202is essentially continuously rotating in response to exhaled air, thisback pressure is created on a periodic or oscillating basis. In otherwords, back pressure “pulses” are established within the patient inlet210, with the back pressure being “released” from the patient inlet 210as the valve plate segments 232, 234 move away from the control ports200 a, 200 b. In some embodiments, the respiratory therapy device 186 isconfigured such that at an exhaled airflow rate of 10 lpm at 100 Padrives the interrupter valve assembly 190 to create 15 pulses per secondat the control ports 200 a, 200 b, with the pressure pulses being atapproximately 3,000 Pa. At flow rates above 10 lpm, the valve structure260 will open and may flutter to maintain inlet pressure to the drivemechanism 204. In related embodiments, the valve structure 260 isconfigured to establish flow of up to 20 lpm at 100 Pa, whichsubstantially maintains the desired back pressure in the patient inlet210 and a rotational speed constant in the range of 10 lpm-30 lpm.Alternatively, however, the respiratory therapy device 186 can beconfigured to exhibit a number of performance characteristics differingfrom those described above.

Another embodiment respiratory therapy device 280 is shown generally inFIG. 16, and is similar in construction to the device 60 (FIG. 2)previously described. In particular, the device 280 includes a housing282 and an interrupter valve assembly 284. The housing 282 is akin tothe housing 62 (FIG. 2 previously described), and generally defines apatient inlet 286, a first chamber 288, a second chamber 290, and supplyinlets 292 (one of which is shown in FIG. 16). As compared to thehousing 62, the first and second chambers 288, 290 are permanentlyfluidly isolated from one another (i.e., the notch 106 (FIG. 4A) is notprovided). The interrupter valve assembly 284 is akin to the interruptervalve assembly 64 (FIG. 2), and includes control ports 294 (one of whichis shown) between the patient inlet 286 and the first chamber 288, avalve body 296 and a drive mechanism 298.

In general terms, the device 280 operates as an “active-only”configuration, whereby the ability to disconnect the pressurized fluidsource 48 (FIG. 1) from the supply inlets 292 and perform a manual,passive oscillatory PEP therapy is not provided. However, CHFO (andoptionally CPAP) therapy is achieved as previously described in a mannerrepresenting a marked improvement over existing CHFO devices. Forexample, the device 280 can be directly connected to virtually anypressurized fluid source and still provide CHFO therapy (i.e., aseparate “driver” unit is not required as the device 280 itself modifiesincoming, constant pressure fluid flow into oscillatory flow to thepatient). Similarly, and unlike existing designs, the device 280 can bemodified as previously described with respect to the device 60 (FIG. 2)to provide additional modes of operation such as delivery of aerosolizedmedication, CPAP, etc., separately or simultaneously with CHFOtreatment.

Yet another alternative embodiment respiratory therapy device 300 inaccordance with principles of the present disclosure is shown in FIG.17. The respiratory therapy device 300 includes a housing 302(referenced generally) and an interrupter valve assembly 304. Thehousing 302 generally includes an outer housing portion 306 and an innerhousing portion 308 that combine to define a first chamber 310(referenced generally in FIG. 17 relative to the outer housing portion306) and a patient inlet 312. The interrupter valve assembly 304includes a valve body 314, a drive mechanism or member 316 and a controlport 318. Details on the various components are provided below. Ingeneral terms, however, upon final assembly, the valve body 314 isselectively associated with the control port 318 (otherwise formed bythe inner housing portion 308). The drive mechanism 316 selectivelycontrols movement of the valve body 314 toward and away from the controlport 318, for example in response to air exhaled by a patient during anexpiratory phase of a breathing cycle, so as to establish a periodicback pressure within the patient inlet 312. This back pressure, in turn,provides an oscillatory PEP therapy to the patient.

The outer housing portion 306 is cylindrical and is sized to receive andmaintain the inner portion 308. With additional reference to FIG. 18A,the outer housing portion 306 defines a first end 320, a second end 322,and an intermediate section 324. The first end 320 forms a passage 326having a diameter or major dimension commensurate with that of acorresponding segment of the inner housing portion 308 such that uponassembly, the outer portion 306 and the inner portion 308 are fluidlysealed at the first end 320. Conversely, the second end 322 forms anopening 328 having a diameter or major dimension greater than acorresponding dimension of the inner housing portion 308 (and any othercomponents attached thereto). With this configuration, the housing 302is fluidly open to ambient at the second end 322. Finally, theintermediate segment 324 similarly defines a diameter or major dimensiongreater than that of the inner housing portion 308 so as to define thefirst chamber 310 between the inner housing portion 308 and theintermediate segment 304 of the outer housing portion 306.

The inner housing portion 308 includes, in some embodiments, amouthpiece 330 and a tube 332. The mouthpiece 330 is adapted forconvenient placement within a patient's mouth (or assembly to separatecomponent (e.g., a nebulizer connection piece) that in turn is adaptedfor placement on a patient's mouth and thus can have, in someembodiments, an oval-like shape as shown in FIG. 17. Regardless, themouthpiece 330 is connected to the tube 332, with the componentscombining to define the patient inlet 312 in the form of a continuouspassage.

The tube 332 can assume a variety of different constructions, andincludes or defines a proximal section 334 and a distal section 336. Asshown in FIGS. 17 and 18A, the tube 332 includes an exterior shoulder338 at the proximal section 334. As described in greater detail below,the shoulder 338 serves as a support or fulcrum for the drive mechanism316 upon final assembly. Regardless, the control port 318 is formed ator adjacent the distal section 336, and establishes a fluid connectionbetween the patient inlet 312 and the chamber 310. While shown as beingpart of the inner housing portion 308, then, the control port 318 iseffectively part of the interrupter valve assembly 304.

In addition to the control port 318, the interrupter valve assembly 304includes the valve body 314 and the drive mechanism 316 as shown in FIG.18A. The valve body 314 is, in some embodiments, a disc having a sizeand shape commensurate with a size and shape of the control port 318(e.g., the valve body 314 can have the same shape dimensions as thecontrol port 318, or can be larger or smaller than the control port318). In some embodiments, the valve body disc 314 is sized to beslightly larger than the control port 318 to better achieve a morecomplete, selective obstruction of the control port 318. As best shownin FIG. 18B, the valve body disc 314 defines opposing first and secondmajor surfaces 340, 342. With the one embodiment of FIG. 18B, the firstsurface 340 is flat. In other embodiments, however, the first surface340 can assume a different shape, such as a hemispherical, conical, etc.Regardless, the first surface 340 is configured to generally mate withan exterior surface 344 of the inner housing portion 308 at which thecontrol port 318 is defined.

Returning to FIG. 18A, the drive mechanism 316 is, in some embodiments,akin to a beam or other cantilevered-type device, and includes a leadingend 350 and a trailing end 352. The leading end 350 is affixed to thevalve body 314, whereas the trailing end 352 is adapted for assembly tothe shoulder 338 of the inner housing portion 308. As described below,the drive mechanism 316 serves as a cantilever beam, and thus exhibits adesired stiffness for repeated, cyclical deflection. With this in mind,in some embodiments, the drive mechanism/beam 316 is formed of a steelspring, although other materials are also acceptable.

Finally, and as shown in FIGS. 17-18B, in some embodiments therespiratory therapy device 300 further includes a valve assembly 354mounted to the inner housing portion 308. The valve assembly 354 canassume a variety of configurations, and can be akin to a one-way valve(e.g., flap or umbrella check valve). Thus, in some embodiments, thevalve assembly 354 includes a frame 356 forming one or more apertures358, along with a valve structure 360 that selectively obstructs theapertures 358. With this configuration, the valve assembly 354 permitsambient airflow into the tube 332/patient inlet 312, but restricts orprevents airflow outwardly from the tube 332/patient inlet 312.

Assembly of the respiratory therapy device 300 includes affixment of thevalve assembly 354 to the distal section 336 of the inner housingportion 308. The trailing end 352 of the drive mechanism beam 316 isassembled (e.g., welded, bonded, etc.) to the shoulder 338 of the innerhousing portion 308. As shown in FIG. 18A, upon assembly, the drivemechanism beam 316 is substantially straight and positions or aligns thevalve body 314 with or “over” the control port 318.

In the neutral or resting state of FIG. 18A, then, the valve body 314 isin highly close proximity to the control port 318 so as to overtlyrestrict fluid flow through the control port 318. In some embodiments,and as best shown in FIG. 18B, the drive mechanism 316 is configuredsuch that with the drive mechanism beam 316 in the neutral or restingstate, a slight gap 362 is established between the valve body 314 andthe exterior surface 344 of the inner housing portion 308 (otherwisedefining the control port 318). A size of the gap 362 dictates a levelof pressure drop within the patient inlet 312, with a dimension of thegap 362 having an inverse relationship to pressure drop within thepatient inlet 312. With this in mind, in some embodiments, the gap 362is less than 0.1 inch; and in other embodiments, less than 0.08 inch,and in yet other embodiments, is less than 0.04 inch. Alternatively,however, other dimensions are also acceptable, including elimination ofthe gap 362. It has surprisingly been found, for example, that where thecontrol port 318 has a diameter on the order of 0.28 inch, the valvebody 314 is a disc having a diameter on the order on 0.36 inch and amass of 11.6 grams, where the drive mechanism beam 316 is formed ofstainless steel and has a length on the order of 2.5 inches, a desiredpressure drop/response of the respiratory therapy device 300 at 20 lpmflow rate is achieved with a dimension of the gap 362 being 0.011 inch.In particular, the respiratory therapy device 300 exhibited, in someembodiments, a pressure drop at 20 lpm flow rate in the range of100-2,500 Pa.

During use, the therapy device 300 is provided to a patient along withinstructions on desired orientation during use. In this regard, and insome embodiments, the therapy device 300 provides optimal performancewhen the control port 318 is spatially positioned at a “side” of thetherapy device 300 as held by a patient. The oval or oblong shape of themouthpiece 330 provides the patient with a visual clue of this desiredorientation. While the therapy device 300 can operate when spatiallyoriented such that the control port 318 is facing “downwardly” (e.g., inthe orientation of FIGS. 18A and 18B), or “upwardly,” an uprightorientation may better account for the effects of gravity duringoperation of the interrupter valve assembly 304.

Notwithstanding the above, operation of the therapy device 300 isdescribed with reference to FIGS. 19A and 19B with the therapy device300 in an otherwise “downward” orientation for ease of illustration. Itwill be understood, however, that in other embodiments, the therapydevice 300 is preferably spatially held by a patient such that thecontrol port 318/valve body 314 is at a “side” of the therapy device asheld (i.e., into the page of FIGS. 19A and 19B). With this in mind,following insertion of the mouthpiece 330 (or other component assembledto the mouthpiece 330) into the patient's mouth, the patient performsmultiple breathing cycles. During the inspiratory phase, ambient airflowreadily enters the patient inlet 312 via the aperture 358/valve assembly354. During the expiratory phase, exhaled air from the patient is forcedthrough the patient inlet 312 and toward the distal section 336 of thetube 332. The valve assembly 354 prevents exhaled air from exiting thetube 332 via the apertures 358. Instead, the exhaled airflow is directedto and through the control port 318; airflow exiting the control port318 exerts a force onto the valve body 314 in a direction away from thetube 332 (and thus away from the control port 318), as shown by arrowsin FIG. 19A. The drive mechanism beam 316 deflects to permit movement ofthe valve body 314 in response to the force, pivoting at the shoulder338. As the valve body 314 moves away from the control port 318,pressure drops within the patient inlet 312, and the airflow proceeds tothe chamber 310 and then to ambient environment via the opening 328.

The drive mechanism beam 316 is configured to deflect only a limitedextent in response to expected forces on the valve body 314 (i.e.,expected airflow pressures at the control port 318 in connection with anadult patient's expiratory phase of breathing), and thus resists overtmovement of the valve body 314 away from the control port 318. Inaddition, as the valve body 314 is further spaced from the control port318, the force placed upon the valve body 314 by airflow/pressure fromthe control port 318 inherently decreases due to an increased area ofthe gap 362. At a point of maximum deflection (FIG. 19A), a spring-likeattribute of the drive mechanism beam 316 subsequently forces the valvebody 314 back toward the control port 318, such that the valve body 314again more overtly obstructs airflow through the control port 318. Thedrive mechanism beam 316 ultimately returns to the near-neutral positionof FIG. 19B in which the valve body 314 substantially closes the controlport 318, and a back pressure is again established within the patientinlet 312. The attendant force on the valve body 314 then increases,causing the drive mechanism beam 316 to again deflect as describedabove. This cyclical movement of the interrupter valve assembly 304continues throughout the expiratory phase, thereby creating aperiodically-occurring back pressure within the patient inlet 312. Thepatient, in turn, experiences an oscillatory PEP treatment, with thepatient's exhaled air serving as the sole input force to the drivingmechanism beam 316.

Although the respiratory therapy device 300 has been described inconnection with a cantilever-type resonator interrupter valve assembly304, in other embodiments, a differing configuration can be employed.For example, FIG. 20 schematically illustrates an alterative embodimentinterrupter valve assembly 370 in connection with a tube 372 otherwiseforming a patient inlet 373 and a control port 374. As a point ofreference, the tube 372 of FIG. 20 is akin to the tube 332 of FIG. 18A.Regardless, the interrupter valve assembly 370 employs a rocker-typearrangement, and includes a valve body 376 and a drive mechanism 378.The valve body 376 is sized in accordance with a size of the controlport 374 (e.g., identical, slightly smaller, or slightly larger), and ismaintained or driven by the drive mechanism 378. In this regard, thedrive mechanism 378 includes an aim or member 380, a support 382, and abiasing device 384.

The arm 380 maintains the valve body 376 and is pivotally mounted to thesupport 382 at a pivot point 386. The arm 380 includes a first side 388at which the valve body 376 is formed or affixed, and an opposite,second side 390. As shown, the second side 390 is configured to provideadditional mass to offset a mass of the valve body 376. Regardless, thesupport 382 pivotally maintains the arm 380 and can be assembled to, orformed as part of, the tube 372.

The biasing device 384 exerts a biasing force onto the valve body 376opposite the control port 374. In some embodiments, the biasing device384 is a coil spring secured at a first end 392 to the valve body376/arm 380 and at an opposite, second end 394 to a support structure396 (drawn generally in FIG. 20). As a point of reference, in someembodiments, the support structure 396 can be formed by, or provided aspart of, the outer housing portion 306 (FIG. 18A).

Regardless of exact construction, the interrupter valve assembly 370provides a balanced rocker arrangement, with the biasing device 384serving as a stiffness element. During use, the valve body 376 limitsairflow from the patient inlet 373/control port 374, with the distanceor gap between the valve body 376 and the control port 374 (and thus theresistance to expiratory airflow) being cyclically dictated by thebiasing device 384. Once again, as the valve body 376 approaches thecontrol port 374, a back pressure is created within patient inlet 373(in conjunction with continued airflow from the patient during theexpiratory phase of breathing). With this arrangement, then, anoscillatory PEP therapy can be delivered, with the interrupter valveassembly 370 operating independent of a spatial orientation of thecorresponding respiratory therapy device/housing. Though not shown, anadditional nebulizer port(s) can be provided with, or formed by, thehousing 302 through which aerosolized medication can be delivered to thepatient.

Yet another alternative embodiment interrupter valve assembly 400 isshown schematically in FIGS. 21A and 21B. As best shown in FIG. 21B, theinterrupter valve assembly 400 is associated with a tube 402 that isakin to the tube 332 (FIG. 18A) previously described, and otherwisedefines a patient inlet 404 and a control port 406.

With the above conventions in mind, the interrupter valve assembly 400includes the control port 406, a valve body 408, and a drive mechanism410. Once again, the valve body 408 is sized and shaped in accordancewith the size and shape of the control port 406, as previously described(e.g., identical, slightly larger, slightly smaller, etc.). With theembodiment of FIGS. 21A and 21B, the drive mechanism 410 is akin to aproportional spring mass system and includes a fly wheel 412 and abiasing device or member 414. The fly wheel 412 is rotatably mountedrelative to the tube 402, for example by a spindle 416. As shown in FIG.21A, for example, the spindle 416 can be mounted or held by varioussurfaces 418 a, 418 b provided with a housing (not shown) of thecorresponding therapy device. Regardless, the fly wheel 412 can freelyrotate.

The biasing device 414 defines a first end 420 and a second end 422. Thefirst end 420 is secured to the valve body 408, whereas the second end422 is secured to the fly wheel 412, for example by a finger 424 asshown in FIG. 21A. In some embodiments, the biasing device 414 is alinear spring, but in other embodiments can take other forms, such as acoiled torsional spring.

Regardless of exact construction, during use the valve body 408 servesto restrict airflow from the patient inlet 404 through the control port406. In this regard, a level of resistance to airflow (and thus backpressure created within the patient inlet 404 during expiratory phase ofa patient's breathing cycle) is a function of a gap 426 (FIG. 21B)between the valve body 408 and the control port 406. The drive mechanism410, in turn, dictates a size or dimension of this gap. In particular,as exhaled air is directed through the control port 406, the valve body408 is forced away from the control port 406, with the biasing device414 providing a resistance to the airflow force placed upon the valvebody 408. Further, as the valve body 408 is moved away from the controlport 406, the force is translated onto the biasing device 414, and thenonto the fly wheel 412. As a result, the fly wheel 412 slightly rotates(e.g., counterclockwise relative to the orientation of FIG. 21B). At acertain point, a spring force of the biasing device 414 overcomes aforce of the airflow through the control port 406, such that the biasingdevice 414 forces the valve body 408 back toward the control port 406.In this regard, the fly wheel 412 serves as a guide for movement of thevalve body 408, ensuring that the valve body 408 moves back towardalignment with the control port 406. In this manner then, a periodicback pressure is created within the patient inlet 404, thus effectuatingan oscillatory PEP therapy to the patient during the patient'sexpiratory phase of breathing.

Although the respiratory therapy device 300 (FIG. 17), along with thevarious interrupter valve assemblies 370 (FIG. 20), 400 (FIGS. 21A,21B), has been described in the context of a passive-only device (e.g.,providing oscillatory PEP therapy in response to the patient's exhaledbreath), in other embodiments, similar design configurations can beemployed to provide a respiratory therapy device capable of operating inboth a passive mode (e.g., oscillatory PEP) and an active mode (e.g.,CHFO). For example, FIG. 22 illustrates another alternative embodimentrespiratory therapy device 440 in accordance with aspects of the presentinvention. The respiratory therapy device 440 is highly similar to therespiratory therapy device 300 (FIG. 17) previously described, andincludes a housing 442 and an interrupter valve assembly 444 including afirst interrupter valve sub-assembly 446 and a second interrupter valvesub-assembly 448. Once again, the housing 442 includes an outer portion450 and an inner portion 452 that combine to define a chamber 454. Theinner portion 452 includes a mouthpiece 456 and a tube 458 that combineto define a patient inlet 460. Further, the tube 458 forms a firstcontrol port 462 fluidly connecting the patient inlet 460 and thechamber 454. In this regard, the first interrupter valve sub-assembly446 is akin to the interrupter valve assembly 304 (FIG. 17) previouslydescribed, and provides oscillatory back pressure within the patientinlet 460 in response to exhaled air. In other words, the firstinterrupter valve sub-assembly 446 operates as previously described,establishing oscillatory PEP therapy.

In addition to the above, the housing 442 includes a supply inlet 464extending from the inner housing portion 452 and exteriorly from theouter housing portion 450. The supply inlet 464 is configured for fluidconnection to an external source of pressurized fluid (not shown, butakin to the pressurized fluid source 48 of FIG. 1), and is fluidlyconnected to a second control port 466 formed by, or connected to, thetube 458.

With the above in mind, the second interrupter valve sub-assembly 448 isakin to the first interrupter valve sub-assembly 446 and includes thesecond control port 466, a valve body 468 and a drive mechanism ormember 470. The valve body 468 has a size and shape commensurate with asize and shape of the second control port 466, such that the valve body468 can obstruct fluid flow through the second control port 466. Thoughnot shown, various relief port arrangement(s) and related valvestructure(s) can further be included in connection with the secondinterrupter valve sub-assembly 448 to ensure adequate pressure isreached to produce desired pressure pulse/volume, and/or entrainment ofambient air.

The drive mechanism 470 is, in some embodiments, an elongated beamhaving a first end 472 and a second end 474. The first end 472 maintainsthe valve body 468, whereas the second end 474 is configured formounting to an interior shoulder 476 that in some embodiments is formedor provided by the tube 458.

Upon final assembly, then, the valve body 468/drive mechanism 470 areinteriorly positioned within the tube 458, with the valve body 468 beingaligned with the second control port 466. During use, positive airflowis established within the patient inlet 460, with the fluid flow beingdirected to the second control port 466. The second interrupter valvesub-assembly 448 operates to periodically interrupt fluid flow throughthe second control port 466 and into the patient inlet 460. Inparticular, and as previously described, the drive mechanism beam 470moves the valve body 468 in a cyclical fashion relative to the secondcontrol port 466, thereby creating a varying obstruction to fluid flowinto the patient inlet 460. Thus, when operating in an active mode(i.e., when the therapy device 440 is connected to the source ofpressurized fluid 48 of FIG. 1), the respiratory therapy device 440provides CHFO treatment to the patient during the patient's breathingcycle (including the inspiratory phase). Conversely, the therapy device440 can be disconnected from the source of pressurized fluid (and thesupply inlet 464 fluidly closed) and operate in the passive mode toprovide oscillatory PEP therapy. Though not shown, the therapy device440 can incorporate additional features that facilitate use of thetherapy device 440 to deliver aerosolized medication, CPAP therapy(constant or variable), etc., as described above with respect to thedevice 60 (FIG. 2). Even further, the therapy device 440 can be modifiedto serve as an “active-only” device, for example by eliminating thefirst interrupter valve sub-assembly 446.

Yet another alternative embodiment respiratory therapy device 500 isshown in FIGS. 23A and 23B. The respiratory therapy device 500 includesa housing 502 (referenced generally) and an interrupter valve assembly504 (referenced generally). Details on the various components areprovided below. In general terms, however, the housing 502 maintains theinterrupter valve assembly 504, and forms a patient inlet 506 fluidlyconnected to a chamber 508 via a control port 510. The interrupter valveassembly 504 includes a valve body 512 and a drive mechanism 514(referenced generally). During use, the drive mechanism 514 moves thevalve body 512 relative to the control port 510 such that the valve body512 variably restricts airflow through the control port 510. In thisway, a pulsed back pressure is created within the patient inlet 506,thereby delivering an oscillatory PEP therapy.

The housing 502 includes an outer portion 520, an inner portion 522, andan orifice body 524. The outer portion 520 provides an exterior framecontoured for convenient handling of the therapy device 500 by a user,and maintains the various components thereof.

The inner housing portion 522 includes a mouthpiece 526 and a tube 528.The mouthpiece 526 is sized and shaped for convenient placement within apatient's mouth (or assembly to a separate component adapted forplacement in a patient's mouth, such as a nebulizer connector piece),and can be integrally formed with the tube 528. Regardless, themouthpiece 526 and the tube 528 combine to define the patient inlet 506through which airflow to and from the patient directly occurs. In thisregard, the tube 528 extends from the mouthpiece 526 to a trailing side530.

With additional reference to FIG. 24, the orifice body 524 is assembledto, or formed as part of the tube 528 at the trailing side 530 thereof.The orifice body 524 includes a rim 532 and a wall 534. As best shown inFIG. 24, the control port 510 is formed in the wall 534. In addition,the wall 534 forms a relief port arrangement 536, consisting of one ormore apertures 538. The relief port arrangement 536 maintains a valvestructure 540 that otherwise allows airflow through the apertures 538 inonly a single direction. Regardless, the rim 532 forms a slot 542 thatis adjacent the control port 510. With this configuration, a bodyinserted through the slot 542 can selectively obstruct all or a portionof the control port 510.

Returning to FIGS. 23A and 23B, the valve body 512 is sized for slidableinsertion within the slot 542 and includes a leading segment 544 and atrailing segment 546. The leading segment 544 is sized for slidableplacement within the slot 542, and in some embodiments has a taperedshape. Regardless, the trailing segment 546 is configured for attachmentto corresponding components of the drive mechanism 514 as describedbelow.

With the embodiment of FIGS. 23A and 23B, the drive mechanism 514 isconfigured to operate as an EMF resonator and includes a resonatorsystem 548 (comprised of a beam or member 550 and a micromotor assembly552), control circuitry 554, an actuator 556, and a power source 558. Ingeneral terms, the power source 558 powers the micromotor assembly 552.In response to a user prompt at the actuator 556, the circuitry 554activates the micromotor 552 that in turn causes the beam 550 toresonate, in some embodiments at a natural frequency of the beam.Regardless, the beam 550 vibrates, causing the attached valve body 512to move relative to the control port 510.

The beam 550 is relatively thin and is formed from a stiff material. Insome embodiments, the beam 550 is formed of steel that otherwiseexhibits low damping characteristics; alternatively, other materialssuch as plastic, ceramic, etc., may also be employed. For example, wherethe beam 550 is formed of steel, it can have a thickness on the order of0.01 inch. Where differing materials are employed, a nominal thicknessof the beam 550 may be increased or decreased.

As described in greater detail below, during use, the beam 550 issubjected to a vibrational force, causing a leading portion 560 thereofto resonate (whereas a trailing portion 562 is held stationary). Withthis in mind, in some embodiments, the beam 550 is constructed (e.g., interms of material and dimensions) so as to not only fit within a desiredfootprint of the housing outer portion 520, but also to exhibit anatural frequency above a desired level such that when the micromotorassembly 552 and the valve body 512 are attached to the leading section560, the resultant natural frequency of the resonator system 548 willapproximate a desired natural frequency. For example, in someembodiments, a desired natural frequency of the resonator system 548 (atthe leading section 560 of the beam 550) is approximately 15 Hz. In theabsence of a mass of the micromotor assembly 552 and the valve body 512,then, the beam 550 exhibits, in some embodiments, a natural frequencywell above 15 Hz (for example, on the order of 40-80 Hz). With a mass ofthe valve body 512 and the micromotor assembly 552 in mind, then,additional mass can be added to the beam 550 to “fine tune” the overallnatural frequency of the resonator system 548 to approximate 15 Hz. Ofcourse, in other embodiments, other frequencies exhibited by the beam550 alone and/or in combination with the micromotor assembly 552 and thevalve body 512 are also acceptable.

As best shown in FIG. 23A, the micromotor assembly 552 includes avariable speed micromotor 570 that rotates an output shaft 572. Anunbalanced mass 574 is mounted to the output shaft 572. With thisconfiguration, then, operation of the micromotor assembly 552 generatesa vibrational force load at the running frequency. The micromotor 570can assume a wide variety of forms, and in some embodiments micromotoris a brushed, direct current (DC) motor, adapted to rotate the outputshaft 572 at a rotational speed proportional to the input voltagesupplied to the micromotor 570. For example the micromotor 570 can beakin to a micromotor used in cell phone application for generating avibrational force, for example a micromotor manufactured by MaduchiMotor Co. under the trade designation Model RF-J2WA. Regardless, themicromotor 570 is electronically connected to the circuitry 554 that inturn regulates voltage supply to the micromotor 570 from the powersource 558.

The control circuitry 554 is, in some embodiments, a control chip orcircuit board adapted to regulate the voltage applied to the micromotor570 and limit current to the micromotor 570 based on displacement andfrequency of the valve body 512/beam 550. In this regard, the controlcircuitry 554 is adapted to monitor the beam 550, effectively viewingthe beam 550 as a capacitor. With this approach, a measurement of bothdisplacement and frequency can be made. More particularly, the frequencymeasurement can be used to control the output voltage to the micromotor570 and maintain a desired speed, while the displacement measurement canbe used to shift the speed of the micromotor 570 to avoid hitting “hard”stops on the beam 550. As a point of reference, if the beam 550 hits a“hard” stop, the beam 550 will stop oscillating and will require time toregain the correct valve opening and frequency. One exemplary schematicconfiguration of the control circuitry 554 is provided in FIG. 25. Itwill be understood, however, that this is but one acceptableconfiguration.

Returning to FIGS. 23A and 23B, the actuator 556 is configured to promptthe control circuitry 554 to initiate or stop delivery of power to themicromotor 570. In this regard, the actuator 556 can assume a variety offorms, and in some embodiments is a button or similar body projectingfrom the housing outer portion 520. Alternatively, the actuator 556 canassume a variety of other forms, for example a membrane-based sensor,wireless actuator, etc.

Finally, the power source 558 provides appropriate power to themicromotor 570 and the control circuitry 554. In some embodiments, thepower source 558 is carried within a compartment 576 of the housing 502,and can assume any appropriate form (e.g., one or more batteries).

The respiratory therapy device 500 is shown in assembled forms in FIGS.26A and 26B. In particular, the valve body 512 is assembled to theleading section 560 of the beam 550 such that the leading segment 544extends away from the beam 550. The micromotor assembly 552 is mountedto the trailing segment 546 of the valve body 512 as best shown in FIG.26A. In this regard, while the trailing segment 546 is adapted toreceive the micromotor assembly 552, in other embodiments, themicromotor assembly 552 can be mounted directly to the beam 550.

The orifice body 524 is coupled to the trailing side 530 of the tube 528such that the wall 534 extends across the tube 528. As shown in FIG.26A, the one-way valve structure 540 is assembled to the relief portarrangement 536 so as to control fluid flow through the apertures 538.

The beam 550 is then assembled to the housing 502 such that the trailingsection 562 is affixed relative to the housing 502, and the valve body512 slidably extends within the slot 542 of the orifice body 524. Asbest shown in FIG. 26B, in a natural state of the beam 550, the leadingsegment 544 of the valve body 512 partially obstructs the control port510. Further, and as best shown in FIG. 26A, a slight gap 582(referenced generally) is established between the valve body 512 and thewall 534 of the orifice body 524 (and thus the control port 510).

The power source 558 is assembled to the housing 502 as shown, andelectrically connected to the control circuitry 554 and the micromotor570, for example via wiring (not shown). The control circuitry 554, aswell as the actuator 556, are similarly assembled to the housing 502.

During use, the micromotor assembly 552 is operated to resonate the beam550, and thus the valve body 512. As indicated above, in someembodiments, the resonator system 548 (i.e., the beam 550, micromotor552, and the valve body 512) is constructed to exhibit a naturalresonation frequency approximating a desired frequency of movement ofthe valve body 512 relative to the control port 510. By exciting theresonator system 548 (and thus the beam 550) at the selected naturalfrequency, the input force and function can be smaller than the forcerequired to deflect the beam 550 alone, thus resulting in reduced powerrequirements. Thus, as the motor assembly 552 vibrates, the beam 550resonates, causing the valve body 512 to move back and forth (e.g., upand down relative to the orientation of FIG. 26B) relative to thecontrol port 510. As such, with resonation of the beam 550, the valvebody 512 selectively “opens” and obstructs the control port 510 in anoscillating fashion.

Regardless of whether the micromotor 570 is powered, during theinspiratory phase of a patient's breathing cycle, ambient air readilyenters the patient inlet 506 via the relief port arrangement 536. Duringthe expiratory phase (and with appropriate activation of the drivemechanism 514 via the actuator 556), the drive mechanism 514 causes thevalve body 512 to open and close the control port 510 in an oscillatingfashion. For example, and with reference to FIG. 27A, as the beam 550resonates downwardly (relative to the orientation of FIG. 27A), thevalve body 512 essentially closes the control port 510 such that exhaledairflow within the patient inlet 506 cannot flow through the controlport 510. As a result, a back pressure is created within the patientinlet 506. Conversely, and as shown in FIG. 27B, as the beam 550resonates upwardly (relative to the orientation of FIG. 27B), the valvebody 512 is radially displaced from the control port 510, such thatairflow within the patient inlet 506 easily passes through the controlport 510 and into the chamber 508 (and thus is exhausted to ambient). Inthis regard, the control circuitry 554 operates to regulate power supplyto the motor assembly 570 so as to consistently resonate the beam 550 ata desired frequency (e.g., 15 Hz). Regardless, the periodic backpressure created within (and release from) the patient inlet 506 duringthe expiratory phase of the patient's breathing cycle effectuates anoscillatory PEP treatment for the patient. In other embodiments, one ormore nebulizer port(s) (not shown) can be provided with, or formed by,the housing 502 to facilitate delivery of aerosolized medication to thepatient. Similarly, a nebulizer connection piece (not shown) can befluidly connected in-line to the mouthpiece 526.

Although the respiratory therapy device 500 has been described asoperating or providing only a passive mode (e.g., oscillatory PEP), inother embodiments, similar design characteristics can be employed inproviding a therapy device capable of operating in both a passive modeas well as an active mode (e.g., CHFO). For example, FIG. 28 illustratesanother embodiment respiratory therapy device 600 that is highly similarto the therapy device 500 (FIG. 22A) previously described. Moreparticularly, the respiratory therapy device 600 includes the housing502 and the interrupter valve assembly 504 components as previouslydescribed, as well as a supply inlet 602. The supply inlet 602 isadapted for fluid connection to an external source of pressurized fluid(not shown, but akin to the pressurized fluid source 48 of FIG. 1), andterminates at a nozzle end 604. As shown, the nozzle end 604 directsfluid flow from the supply inlet 602 toward the control port 510.Further, a position of the nozzle end 604 relative to an exterior of thehousing 502 allows for entrainment of ambient air into the fluid flowfrom the nozzle end 604. Additional valving (not shown) can optionallybe provided to prevent occurrences of stacked breaths.

In a passive mode of operation (i.e., the supply inlet 602 isdisconnected from the pressurized fluid source), the therapy device 600operates as previously described (e.g., during the expiratory phase ofthe patient's breathing cycle, the drive mechanism 514 resonates thevalve body 512 relative to the control port 510 so as to establish aperiodic back pressure within the patient inlet 506 in providingoscillatory PEP therapy). In an active mode of operation, positive fluidflow is forced through the supply inlet 602 and directed by the nozzleend 604 toward the control port 510. In connection with this forcedsupply of airflow, the drive mechanism 514 again causes the valve body512 to resonate relative to the control port 510, thus cyclicallyinterrupting fluid flow from the nozzle end 604 through the control port510, and thus into the patient inlet 506. Thus, in the active mode ofoperation, the respiratory therapy device 600 operates to provide CHFOtreatment to the patient during an entirety of the breathing cycle(including at least the inspiratory phase of breathing). Though notshown, the therapy device 600 can incorporate additional features thatfacilitate use thereof to delivery aerosolized medication, CPAP therapy,etc., as described above with respect to the device 60 (FIG. 2). Evenfurther, the therapy device 600 can be modified to serve as an“active-only” device, for example by providing an exhaust valvearrangement between the mouthpiece 506 and the control port 510.

The respiratory therapy device of the present invention provides amarked improvement over previous designs. In some embodiments, astandalone respiratory therapy device is provided, capable of operatingin a passive mode and an active mode. In the passive mode, the therapydevice effectuates an oscillatory PEP treatment to the patient, and withmany embodiments does so solely in response to the patient's exhaledbreath. In the active mode of operation, an external source ofpressurized fluid is connected to the device with the deviceindependently affecting fluid flow from the external source to provideCHFO treatment. Unlike existing configurations, embodiments of thepresent disclosure providing an active mode of operation can beconnected to virtually any pressurized fluid source (e.g., regulated ornon-regulated wall source, home compressor, oxygen tank, amechanical/pneumatic flow interrupter or “driver,” standalone ventilatorsystem, etc.). In this regard, when connected to an existing flowinterrupter/driver that otherwise generates pressurized fluid in pulsedform, the driver can provide the ability to “tailor” the actual therapydelivered to a particular patient. In yet other embodiments, therespiratory therapy device provides passive therapy (e.g., oscillatoryPEP) in a manner not previously considered. In yet other embodiments, animproved “active-only” therapy device is provided. Further, with any ofthe embodiments, additional therapies can be provided, such as CPAPand/or nebulizer treatments.

Although the present invention has been described with respect topreferred embodiments, workers skilled in the art will recognize thatchanges can be made in form and detail without departing from the spiritand scope of the present invention.

1. An oscillating positive expiratory pressure therapy device for use bya patient, the device comprising: a housing sized for handling by apatient and defining a patient breathing passage extending from apatient end and through which a patient to be treated inhales andexhales air; and an interrupter valve assembly carried by the housingand including: a control port through which expiratory airflow isreleased from the patient breathing passage, a valve body sized to atleast partially obstruct fluid flow through the control port, a drivemechanism operating in response to expiratory airflow, the drivemechanism configured to rotate the valve body relative to the controlport, wherein the interrupter valve assembly is configured such thatwith rotation, the valve body repeatedly transitions between a positionof maximum obstruction and a position of minimum obstruction relative tothe control port.
 2. The device of claim 1, wherein the interruptervalve assembly includes two control ports through which expiratoryairflow is released from the patient breathing passage.
 3. The device ofclaim 1, wherein the valve body includes two valve plates segmentsarranged to selectively obstruct the control port.
 4. The device ofclaim 1, wherein the interrupter valve assembly further includes a driveshaft connecting the valve body and the drive mechanism such thatrotation of the drive shaft causes the valve body to selectivelyobstruct the control port.
 5. The device of claim 4, wherein the drivemechanism is adapted to rotate the shaft.
 6. The device of claim 5,wherein drive mechanism includes first and second lobe bodies.
 7. Thedevice of claim 6, wherein the housing further includes a first chamberseparated from the patient breathing passage by a wall in which thecontrol port is formed, and further wherein the valve body is maintainedwithin the first chamber.
 8. The device of claim 7, wherein the housingfurther includes a second chamber adjacent the first chamber, andwherein the lobe bodies are maintained within the second chamber.
 9. Thedevice of claim 8, wherein the first and second chambers are fluidlyconnected by an aperture such that fluid flow from the first chamber tothe second chamber acts upon the lobe bodies to cause rotation thereof.10. The device of claim 9, wherein the second chamber forms an outletopening fluidly connected to an exhaust outlet.
 11. The device of claim9, wherein the housing further forms a relief port arrangement in thefirst chamber apart from the control port, the device further includinga valve structure controlling fluid flow through the relief portarrangement such that when a fluid pressure within the first chamberexceeds a predetermined level, the valve structure fluidly opens therelief port arrangement.
 12. The device of claim 11, wherein the housingfurther forms an exhaust chamber defining the exhaust outlet and fluidlyconnected to the first chamber via the relief port arrangement.
 13. Thedevice of claim 12, wherein the exhaust chamber is fluidly connected tothe second chamber via an outlet opening.
 14. An oscillating positiveexpiratory pressure therapy device for use by a patient, the devicecomprising: a housing sized for handling by a patient and defining apatient breathing passage extending from a patient end and through whicha patient to be treated inhales and exhales air; and an interruptervalve assembly carried by the housing and including: a control portthough which expiratory airflow is released from the patient breathingpassage, a valve body sized to at least partially obstruct fluid flowthrough the control port, a member having a first end attached to thevalve body and a second end opposite the first end, the member beingassembled to control a position of the valve body relative to thecontrol port; wherein the interrupter valve assembly is configured tooperate in response to expiratory airflow from the patient toselectively move the valve body relative to the control port in creatingan oscillatory positive expiratory pressure effect, a distance betweenthe second end of the member and the control port remaining fixed duringoperation of the interrupter valve assembly.
 15. The device of claim 14,wherein the member is rotatably maintained within the housing, andfurther wherein rotation of the member causes the valve body toselectively obstruct the control port.
 16. The device of claim 15,wherein the interrupter valve assembly further includes a drivemechanism for rotating the member.
 17. The device of claim 16, whereinthe drive mechanism includes first and second lobe bodies.
 18. Thedevice of claim 17, wherein the housing includes a first chamberseparated from the patient breathing passage by a wall in which thecontrol port is formed, and further wherein the valve body is disposedwithin the first chamber.
 19. The device of claim 18, wherein thehousing further includes a second chamber adjacent the first chamber,and further wherein the lobe bodies are maintained within the secondchamber.
 20. The device of claim 19, wherein the first and secondchambers are fluidly connected by an aperture such that fluid flow fromthe first chamber to the second chamber acts upon the lobe bodies tocause rotation thereof.
 21. The device of claim 20, wherein the secondchamber forms an outlet opening fluidly connected to an exhaust outlet.22. The device of claim 14, wherein the second end of the member isfixed relative to the housing to define a cantilever beam.
 23. Thedevice of claim 22, wherein the valve assembly is configured such that adistance of travel of the valve body relative to the control port issolely a function of a force constant of the beam and a pressure ofexpiratory airflow at the control port.
 24. The device of claim 14,wherein the valve body defines a contact face positioned to interactwith the control port, the contact face being flat.
 25. An oscillatingpositive expiratory pressure therapy device for use by a patient, thedevice comprising: a housing sized for handling by a patient anddefining a patient breathing passage extending from a patient end andthrough which a patient to be treated inhales and exhales air; and aninterrupter valve assembly carried by the housing and including: acontrol port through which expiratory airflow is released from thepatient breathing passage, a valve body sized to at least partiallyobstruct fluid flow through the control port, a drive mechanismincluding a component configured to rotate in response to expiratoryairflow, wherein the drive mechanism is operable to move the valve bodyrelative to the control port, wherein the interrupter valve assembly isconfigured such that with rotation of the drive mechanism component, thevalve body repeatedly transitions between a position of maximumobstruction and a position of minimum obstruction relative to thecontrol port.
 26. A method of providing respiratory therapy to a patientcomprising: providing a respiratory therapy device including: a housingsized for handling by a patient and defining a patient breathing passageextending from a patient end and through which a patient to be treatedinhales and exhales air, an interrupter valve assembly carried by thehousing and including: a control port through which expiratory airflowis released from the patient breathing passage, a valve body sized to atleast partially obstruct fluid flow through the control port, a drivemechanism for rotating the valve body relative to the control port inresponse to expiratory airflow, placing the patient end into a mouth ofthe patient; breathing by the patient through the patient end, includinginhaling and exhaling, wherein expiratory airflow from the patient intothe device to acts upon the drive mechanism; rotating the valve bodyrelative to the control port by the drive mechanism in response to theexpiratory airflow; and creating an oscillatory positive expiratorypressure effect on the patient with rotation of the valve body.
 27. Amethod of providing respiratory therapy to a patient comprising:providing a respiratory therapy device including: a housing sized forhandling by a patient and defining a patient breathing passage extendingfrom a patient end and through which a patient to be treated inhales andexhales air, an interrupter valve assembly carried by the housing andincluding: a control port through which expiratory airflow is releasedfrom the patient breathing passage, a valve body sized to at leastpartially obstruct fluid flow through the control port, a drivemechanism for moving the valve body relative to the control port inresponse to expiratory airflow, placing the patient end into a mouth ofthe patient; breathing by the patient through the patient end, includinginhaling and exhaling; actuating the drive mechanism to create arotational movement in response to expiratory airflow from the patient;moving the valve body relative to the control port with operation of thedrive mechanism; and creating an oscillatory positive expiratorypressure effect on the patient with movement of the valve body.